There were 22 cases of deaths reported in clinical trials in the year 2010. Global pharma major Bayer, Lilly, Sanofi and Pfizer were sponsors of 14 of these cases. Information on the background of these people who lost their lives during clinical trials by the pharma firms, especially with regard to their socio-economic profiles, is sketchy.
Now, waking up to the need to beef up regulations relating to clinical trials by pharmaceutical firms in the country, especially with the view to check possible exploitation of people from the lower strata of society, the Government has come up with a draft notification for amendments in the Drugs and Cosmetics Rules. The notification — GSR 821 (E) dated November 18, 2011) — attempts to change the current procedure for filling out the ‘Informed Consent' that is taken at the time of the enrolment of trial subjects, effectively ensuring that the socio-economic profiles of the subjects is duly filled in. According to the new notification, the details to be take note of from now on in the ‘Informed Consent' form include the details of address, occupation, annual income of the subject, so as to have information regarding the socio-economic status of the trial subjects. The notification also provides for incorporation of provisions for providing financial compensation to the trial subjects in case of trial-related injury or death. Also, an enhancement of the responsibilities of the Ethics Committees, the sponsors and investigator to ensure that financial compensation as well as medical care is provided to the trial subjects who suffer trial-related injury or deaths, has been provided for in the notification.
The Ethics Committee, which reviews and accords its approval to a trial procedure, is essentially entrusted with the task of safeguarding the rights and well-being of all trial subjects. “Strengthening the role of the Committee is a positive,” a health sector expert said. According to the Ministry of Health and Family Welfare, deaths may occur during clinical trails due to various reasons. “These could be disease-related deaths as in case of cancer or administration of the drug to critically ill patients or side-effects or unrelated causes. Such deaths are investigated for causal relationship by the investigator and by the medical experts of the sponsor… So far, the socio-economic profiles of the trial subjects have not been included in the format for Informed Consent taken at the time of their enrolment.”
